Tag Archives: RWE

Bridging Regulatory & Reimbursement

Everybody is looking for Evidence — Bridging Regulatory & Reimbursement: Strategies for Success

By Christy Sheehy, PhD, Jenny Levinson
Bridging Regulatory & Reimbursement

As medical technology products and services move through the development pipeline, they face the challenge of both showing safety and efficacy for regulatory approval and articulating the value of the diagnostic, treatment or monitoring technology to obtain reimbursement from payers. A 2024 MedExec Women Conference panel highlighted strategies to bridge the evidence needs for regulatory approval and reimbursement to more efficiently bring products to market.

Continue reading

Post-market surveillance

Reliable Active Surveillance: RWE for MedTech

By Amelia Hufford, PhD, Phillip Stoltzfus
Post-market surveillance

As regulatory bodies increasingly recognize the richness and value of RWE, particularly in informing the benefit-risk profile of devices from real-world environments, MedTech companies are turning to advanced analytical tools to navigate this new landscape efficiently.

Continue reading

Harsha Rajasimha, Ph.D.

AI and the Lack of Diversity in Data: Implications and the Path Forward for Rare Disease Research

By MedTech Intelligence Staff
Harsha Rajasimha, Ph.D.

Genomics data scientist Harsha Rajasimha, Ph.D., Founder and Executive Chairman of IndoUSrare, highlights the risks of developing AI/ML algorithms based on biased data, as well as efforts underway to improve global collaboration on the collection and sharing of health data that may help us realize the potential of AI in diagnoses and treatment of rare diseases.

Continue reading